INTRODUCTION

ALMOTAN 12.5MG contains Almotriptan which belongs to a group of medicines called selective Serotonin receptor agonists. ALMOTAN 12.5MG is used for acute treatment of migraines with or without aura (blind spots) in adults and adolescents (aged 12 – 17 years). Migraine is a type of headache that causes moderate to severe throbbing or pulsing pain on one or both sides of your head which is usually characterized by symptoms such as nausea, visual disturbance, dizziness, numbness, tingling, irritability, difficulty speaking, and temporary loss of vision.

Almotriptan is a selective serotonin receptor agonist which works by binding to certain receptors (5-HT1B and 5-HT1D, which is responsible for basic brain function) in the blood vessels of the brain that cause narrowing of the vessels and reduce blood flow to the brain thus resulting in the blockade of transmission of pain signals to the brain which produce relief from the migraine pain.

ALMOTAN 12.5MG is not recommended for use in patients having allergy to Almotriptan or any of the ingredients of this medicine, stroke (brain attack), diseases that restrict blood supply to the heart (such as heart attack, chest pain while at rest and activity, heart problems without pain, severe and uncontrolled mild or moderate high blood pressure), peripheral vascular disease (a circulation disorder that causes obstruction of the large arteries in the arms or legs) and severe liver disease. Before taking ALMOTAN 12.5MG, inform your doctor if you are diabetic, migraine type which has not been diagnosed or have headache symptoms which are different from your usual migraine attacks such as hearing noise in ears, short lived paralysis of one side of the body, paralysis of the muscles that control eye movement. ALMOTAN 12.5MG should be used with caution in pregnant and breastfeeding women and in women with childbearing potential only if it is clearly advised necessary by your doctor. ALMOTAN 12.5MG is also not recommended for use in children (less than 12 years of age). The most common side effects of taking ALMOTAN 12.5MG are dizziness, sleepiness, nausea, vomiting, and tiredness. Contact your doctor if any of the symptoms worsen.

USES OF ALMOTAN 12.5MG

• Used for acute treatment of migraines with or without aura (blind spots) in adults and adolescents (aged 12 – 17 years)

HOW ALMOTAN 12.5MG WORKS

ALMOTAN 12.5MG is a selective serotonin receptor agonist which works by binding to certain receptors (5-HT1B and 5-HT1D, which is responsible for basic brain function) in the blood vessels of the brain that cause narrowing of the vessels and reduce blood flow to the brain thus resulting in the blockade of transmission of pain signals to the brain which produce relief from the migraine pain.

DIRECTIONS FOR USE

Take ALMOTAN 12.5MG as advised by your physician. Swallow ALMOTAN 12.5MG with a glass of water and do not chew or crush the medicine. ALMOTAN 12.5MG can be taken with or without food. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF ALMOTAN 12.5MG

HOW TO MANAGE SIDE EFFECTS

Dizziness:

Try to rest and relax. Get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume too much alcohol, as it can aggravate your dizziness.Consult your doctor if the symptom did not improve.

Nausea and vomiting:

Try to take ALMOTAN 12.5MG with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take ALMOTAN 12.5MG at a time when you can sit down (or lie down) when the symptoms are at their worst. Try not to drive or use tools or machinery until you feel well.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before taking ALMOTAN 12.5MG, inform your doctor, if you are taking any of the following medicine:

• medicines used to treat migraines such as ergotamine, dihydroergotamine and methysergide or other serotonin agonists Ex.sumatriptan
• medicines used to treat depression such as monoamine oxidase inhibitors (Ex moclobemide), selective serotonin reuptake inhibitors (Ex. fluoxetine) or serotonin noradrenaline reuptake inhibitors (Ex. venlafaxine)
• herbal medicine used to treat depression such as st. John’s Wort

Overdosage:

If you or anyone else accidentally takes too much of ALMOTAN 12.5MG, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are sleepiness, nausea, vomiting and chest discomfort.

SYNOPSIS

MORE INFORMATION

• Keep ALMOTAN 12.5MG out of reach in children
• Store ALMOTAN 12.5MG at room temperature

FAQs ABOUT ALMOTAN 12.5MG

What ALMOTAN 12.5MG is used for?

ALMOTAN 12.5MG is used for acute treatment of migraines with or without aura (blind spots) in adults and adolescents (aged 12 – 17 years) which generally cause moderate to severe throbbing or pulsing pain on one or both sides of your head usually characterized by symptoms such as nausea, visual disturbance, dizziness, numbness, tingling, irritability, difficulty speaking, and temporary loss of vision.

How ALMOTAN 12.5MG works in your body?

ALMOTAN 12.5MG works by binding to 5-HT1B and 5-HT1D receptors (proteins responsible for basic brain function) in the blood vessels of the brain that cause narrowing of the vessels and reduce blood flow to the brain thus resulting in the blockade of transmission of pain signals to the brain which produce relief from the migraine pain.

What side effects are seen with ALMOTAN 12.5MG?

The most common side effects of taking ALMOTAN 12.5MG are dizziness, sleepiness, nausea, vomiting, and tiredness. Consult doctor if any of the symptoms gets worse over the time.

Is ALMOTAN 12.5MG safe to use in children?

No. ALMOTAN 12.5MG is not recommended for use in children (less than 12 years of age). If ALMOTAN 12.5MG is accidentally ingested by a child, go to the hospital immediately and consult the doctor for further management.

Can ALMOTAN 12.5MG be taken by pregnant or breastfeeding women?

ALMOTAN 12.5MG should be used with caution in pregnant women only if the expected benefits outweigh any potential risk to the fetus. Consult your doctor before taking ALMOTAN 12.5MG. If you think you may be pregnant or planning to have a baby, then consult your doctor before taking ALMOTAN 12.5MG for an advice. ALMOTAN 12.5MG should be used with caution in breastfeeding women who should avoid breastfeeding for 24 hours after taking this medicine. Consult your doctor before taking ALMOTAN 12.5MG.

REFERENCES

1. KD. Tripathi. 5-Hydroxytryptamine, its antagonists and drug therapy of migraine. Essentials of medical pharmacology. Seventh edition. 2013. Page – 179.

2. Janssen-Ortho LLC.A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in May 2011] [Accessed on 26th April 2022] https://clinicaltrials.gov/ct2/show/NCT00210509

3. Gursharan Sidhu; Charles V. Preuss; Priti Patel. Almotriptan. NIH National Library of  Medicine, National center for biotechnology information. January 2022 [Accessed on 26th April 2022] https://www.ncbi.nlm.nih.gov/books/NBK541092/#:~:text=Go%20to%3A-,Mechanism%20of%20Action,in%20the%20migraine%20relief%20process

4. X Cabarrocas, M Salva, M Pavesi, J Costa. Ethanol does not significantly affect the bioavailability of almotriptan: an open, randomized, crossover, single-dose, phase I clinical trial in healthy volunteers.NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. September 2006 [Accessed on 26th April 2022] https://pubmed.ncbi.nlm.nih.gov/16995333/

5. Mylan Pharmaceuticals ULC. Drug and Health Product Register (HRES). [Revised in June 2016] [Accessed on 26th April 2022] https://pdf.hres.ca/dpd_pm/00035358.PDF

6. SAG Manufacturing S.L.U. Electronic medicines compendium (EMC). [Revised in October 2020] [Accessed on 25th April 2022] https://www.medicines.org.uk/emc/files/pil.11089.pdf